Siemens Healthcare Diagnostics, Inc. Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.

Recommended Action

Per FDA guidance

Siemens issued an Urgent Medical Device Correction (UMDC) ASI21-02.A.US and Urgent Field Safety Notice (UFSN) ASI21-02.A.OUS on 5/13/2021 to all affected customers informing them of the issue and providing instructions the customer must follow until their analyzer is updated with replacement valves that do not have the manufacturing defect. Siemens will release the replacement valves and will begin installation at customer sites in June 2021. Letter states: Actions to be Taken by the Customer The following actions must be taken until your system has been serviced to replace any leaking components. 1. When reporting results, ensure that all QC results are within the laboratory acceptable range before releasing results. A manufacturing defect in some valves may cause them to leak Siemens Healthcare Diagnostics Inc. 2. On the Atellica CH930 Analyzer: If any water droplets are observed on the tips of any Reaction Wash Station or Dilution Wash Station probes, contact Siemens service so that the instrument can be checked for valves that may be failing. 3. On the Atellica IM 1300 or Atellica IM 1600 Analyzers: If any water droplets are observed forming at the tips of any Reagent probes, contact Siemens service so that the instrument can be checked for valves that may be failing. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Technical Support representative. Siemens Service representative will be contacting your laboratory to check and replace the identified valves. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Contact your Siemens Healthineers Customer Care Center or y